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Completed

NCT Number: NCT05760352

Comparison of Multiple Exercise Trainings in Chronic Respiratory Disease

The present study aims to investigate the effect of different exercise training in patients with chronic respiratory disease.

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Key information

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fu Jen Catholic University Hospital, Fu Jen Catholic University

New Taipei City, 24352, Taiwan

About this study

Background: Chronic respiratory and chronic obstructive pulmonary disease is the one of the major causes of global morbidity and mortality. Patients with chronic respiratory disease often experience exercise limitation and physical inactivity due to muscular weakness and severe dyspnea. Symptoms of COPD may contribute to activity restriction, deconditioning, and exercise intolerance. Pulmonary rehabilitation has been demonstrated to improve clinical outcomes and exercise capacity in patients with chronic respiratory disease. However, the optimal exercise training modality is remaining unclear.

Study Design: This is a one-year, single-centre, prospective randomized controlled trial

Methods: The investigators expected a total of 60 participants were be enrolled, then randomly assigned into three groups (control group, experimental-1, and experimental-2). All participants will receive a graded exercise test, then followed a 9-weeks of exercise training. After 9-weeks of exercise training, the maximal oxygen consumption will be analyzed as a primary outcome of this study. Physiological parameters, hemodynamic outcome, respiratory function, and strength of lower limb muscle will be recorded.

Effect: After 9 weeks' exercise training, VO2 will significantly improve in eccentric cycling exercise groups, furthermore, heart rate and perceived exertion will be lower in the eccentric cycling exercise combined with helmet ventilation.

Key words: Pulmonary rehabilitation; eccentric cycling exercise; helmet ventilation; chronic respiratory disease

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age between 20 and 80 years
  • Diagnosed with chronic respiratory diseases
  • Having undergone pulmonary rehabilitation for more than 3 months

Exclusion criteria

  • Existing of tracheostomy
  • Those who use oxygen therapy or ventilator at home
  • Severe left heart failure (NYHA III-IV)
  • Neuromuscular disease
  • Acute exacerbation within the past three months
  • Those who are unable to cooperate with the cardiopulmonary exercise test

Treatment and study plan

Eccentric bike

Device

Received eccentric cycling exercise

Helmet ventilation

Device

Using helmet ventilation during eccentric cycling exercise

Primary outcomes

  1. Peak % of oxygen consumption

    Time frame: 9 weeks

    To observe the maximum exercise performance

Secondary outcomes

  1. Heart rate, b/m

    Time frame: 9 weeks

    Cardiac hemodynamic parameter

  2. Respiratory rate, b/m

    Time frame: 9 weeks

    Pulmonary parameter

  3. Mean arterial blood pressure, mmHg

    Time frame: 9 weeks

    Cardiac hemodynamic parameter

  4. FEV1/FVC, %

    Time frame: 9 weeks

    Pulmonary function

  5. Saturation of Peripheral Oxygen(SpO2), %

    Time frame: 9 weeks

    Blood oxygenation

Sponsors and collaborators

Lead sponsor

Fu Jen Catholic University

Other

Registry information

Official study title

Comparison of Multiple Methods of Exercise Training for Accessing Maximal Oxygen Consumption, Skeletal Muscle Oxygen Saturation, and Cardiopulmonary Outcomes in Patients With Chronic Respiratory Disease

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Mar 8, 2023
Registry last updated
Mar 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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